BACKGROUND:BK virus-associated hemorrhagic cystitis (BKV-HC) still remains a life-threatening complication after Hematopoietic Stem Cell transplantation (HSCT). In this study, we analyzed a possible nosocomial transmission of BK virus (BKV) in a pediatric HSCT clinic. METHODS:All the information of 131 patients who had HSCT in Akdeniz University Hospital pediatric HSCT clinic between July 2019 and July 2022 was screened for BKV-HC. Twenty-six patients developed BKV-HC and 21 of them were related to the nosocomial transmission. Phylogenetic investigation was conducted on a total of 19 patients, comprising 15 pediatric cases believed to be associated with nosocomial transmission. All the patients had BKV DNA positivity in their urine samples and 17 of them also had BKV-HC. A region approximately 677 bp in length was sequenced and after alignment, phylogenetic analysis was done. RESULTS AND CONCLUSION:In phylogenetic analysis, three clusters including 11, 5, and 3 patients having identical sequences were formed. To our knowledge, this is the biggest BKV-HC nosocomial transmission seen among HSCT patients. Nosocomial BKV transmission affecting HSCT patients was proven with phylogenetic and statistical analysis. Furthermore, this study presented a novel finding, describing two HSCT patients affected by nosocomial transmission, evidenced by the presence of BKV-DNA in their urine samples, who had not developed HC. This observation marks the first documented instance of such cases within the context of nosocomial transmission of BKV.
Quantitative detection of hepatitis C virus (HCV) RNA is essential for diagnosis of chronic infection and monitoring the HCV levels in patients under treatment. In this study, we aimed to evaluate the performance characteristics and comparability of a novel DiaRD-HCV RT qPCR kit (Diagen Lts, Ankara, Turkey) with Artus HCV QS-RGQ kit and the NeuMoDx HCV Quant Test in clinical samples. A total of 240 plasma samples, 86 HCV RNA positive and 154 negative, were used for comparison. Intra-assay and inter-assay reproducibility tests of the novel kit were carried out on clinical samples having HCV RNA loads of 1.42 × 103 IU/µl, 1.40 × 104 IU/ml, and 5.10 × 105 IU/ml. HCV genotypes 1b, 2a, 2b, 3a, 4, 5, and 6 were tested by the novel system. DiaRD HCV RTqPCR kit demonstrated a sensitivity of 98.8
Monitoring of viral load is of critical importance in the clinical management of patients at risk of cytomegalovirus (CMV)-related complications following transplantation. Quantitative real-time polymerase chain reaction (qRT-PCR) is one of the most commonly used methods for CMV DNA detection. For this purpose, commercial test kits calibrated according to the International Standard of Quantitation (ISQ) defined by the World Health Organization (WHO) are used. However, measurement variability between different test systems still constitutes a significant problem. The aim of this study was to compare the test results of two different commercial kits, CMV Cobas Ampliprep/Cobas Taqman (CMV-CAP/CTM) (Roche Diagnostics, Mannheim, Germany) and NeuMoDx CMV Quant Assay (Qiagen, Ann Arbor, USA) which have been calibrated with the WHO CMV IQS. The results of 478 plasma samples run simultaneously with the CMV-CAP/CTM and NeuMoDx CMV PCR tests were analyzed. Fully automated steps including extraction, real-time amplification and result analysis were performed according to the manufacturer’s recommendations. CMV DNA was detected in 216 (45.18%) samples and not detected in 82 (17.15%) samples in both tests. A total of 180 (37.65%) samples had discordant results. Statistically, a moderate level of qualitative agreement was found between the qualitative results of both tests (kappa= 0.28, p< 0.001). When the quantitative results obtained in the dynamic measurement range of both tests (n= 104) were examined, the median viral load values measured by CMV-CAP/CTM and NeuMoDx CMV tests were calculated as 1598 IU/mL (range= 137.41-115570) and 2600 IU/mL (range= 55-220000), respectively. According to the correlation analysis, a very strong correlation was found in the comparison of the results of both tests (r= 0.83, p< 0.001). According to the Bland-Altman analysis; the average difference between the CMV-CAP/CTM test and NeuMoDx CMV test values was found to be 0.296 log10 (standard deviation: 0.412) IU/mL (the lowest difference was 0.005 and the highest difference was -1.559 log10 IU/mL), and the CMV-CAP/CTM test gave lower measurements than the NeuMoDx CMV test. In 104 samples with results in the dynamic measurement range of both tests, for log10 IU/mL results, the measurement difference was within ±0.5 log10 IU/mL in 71 (quantitative agreement: 68.3%) samples and the measurement difference was greater than ±0.5 log10 in 33 (31.7%) samples (median= 0.7 log10 IU/ml; range: 0.51-1.56). A measurement difference of more than ±1 log10 was detected in two samples (1.9%). As a result, in the measurements made with CMV-CAP/CTM and NeuMoDx CMV PCR tests, a moderate level of agreement was found for qualitative results in plasma samples, a strong correlation for quantitative values and a biologically significant viral load difference in one-third of the samples was detected. Our study shows that the measurement differences observed between CMV PCR test platforms do not completely disappear even if calibration is provided with the WHO ISQ. In post-transplantation follow-up, considering the measurement differences between test systems and preferring the same sample type and the same test platform in CMV viral load monitoring is important in terms of ensuring consistency in patient management.
Ulusal Viroloji Günleri (2 Kasım 2023, Bodrum)'nde sözlü bildiri olarak
Viral load monitoring is important in identifying patients at risk of developing cytomegalovirus (CMV) related complications after transplantation and for this purpose, quantitative real-time polymerase chain reaction (Rt-qPCR) tests are most commonly used. The main problem in CMV DNA Rt-qPCR tests that make quantitative measurements is that there are significant differences in measurements performed with different kits in different laboratories. Comparability of viral load measurements between laboratories has increased with the introduction of quantitative PCR tests calibrated with the CMV International Quantitation Standard (IQS) developed by the World Health Organization (WHO). However, quantitative agreement between measurements made with different kits has still not been fully achieved. In this study, it was aimed to investigate the quantitative compatibility between measurements made with Cobas 6800 (Roche Diagnostics, Mannheim, Germany) and NeuMoDx (Qiagen, Ann Arbor, USA) CMV DNA Rt-qPCR tests, which are fully automated new generation systems calibrated with the WHO CMV IQS. The results of 214 plasma samples, which were studied simultaneously with Cobas 6800 CMV Rt-qPCR and NeuMoDx CMV Rt-qPCR tests were analyzed. In the tests, the extraction, amplification and detection stages were carried out fully automatically. CMV DNA was detected in 144 (67.28%) samples in both tests and was not detected in 53 (24.76%) samples. Incompatible results were obtained in a total of 17 (7.94%) samples. Good agreement was found between the qualitative results of both tests (kappa= 0.80, p< 0.001). When the quantitative results (n= 129) obtained in the dynamic measurement range of both tests were examined, the median viral load values measured by Cobas 6800 CMV Rt-qPCR and NeuMoDx CMV Rt-qPCR tests were 513 IU/mL (range= 35-37000) and 741 IU/mL (range= 68-48978), respectively. According to the correlation analysis, a very strong correlation was found between the results of both tests (r= 0.94, p< 0.001). According to Bland-Altman analysis; the average difference between the results of the NeuMoDx CMV Rt-qPCR test and the Cobas 6800 CMV Rt-qPCR test was found to be-0.14 log(10) [standard deviation (SD)= 0.231 IU/mL and it was determined that the Cobas 6800 CMV Rt-qPCR test had lower measurements than the NeuMoDx CMV Rt-qPCR test. In 120 of 129 samples (93%) whose results were within the dynamic measurement range of both tests, the measurement difference was within +/- 0.5 log(10) IU/mL and in 9 (7%), it was detected as more than +/- 0.5 log(10) (median 0.54 log(10) IU/ml; range= 0.51-0.81). No measurement difference of more than +/- 1.0 log(10) was detected in any sample. In this study, quantitative agreement was found in the measurements made in plasma samples with the fully automated Cobas 6800 CMV Rt-qPCR and NeuMoDx CMV Rt-qPCR tests calibrated with the CMV IQS. To the best of our knowledge, a study comparing viral load measurements made with Cobas 6800 and NeuMoDx fully automated systems in the detection of CMV DNA has not yet been conducted, and this is the first study on this subject.
Objective: This study aimed to determine the seroprevalence of SARSCoV-2 in pediatric patients with rheumatic disease during the COVID-19 pandemic and to evaluate the effects of medication used for rheumatic disease on seroprevalence. Material and Methods: Between September 2020 and September 2021, 170 patients aged 2-18 years with a diagnosis of rheumatological disease and with a follow-up period of higher than six months were included in the study. Anti-SARS-CoV-2 antibodies against the S1 domain of the SARSCoV-2 spike protein were investigated with a micro ELISA kit. Results: Of the 170 patients, 92 (54.1%) were females, and the mean age was 12.16 +/- 4.18 years. MEFV mutation was investigated in 131 of the patients. Of the patients, 14.7% were on steroids and 16.5% were on biologic agents. Anti-SARS-CoV-2 IgG antibody was positive in 40 (23.5%) of the patients. IgG seropositivity of the patients with and without MEFV mutation were similar (p= 0.991). IgG was positive in 25% of the patients with biologic agents and in 23.2% of those who did not (p= 0.505). Thirty-eight (22.4%) of the patients had close contact with an individual diagnosed with COVID-19. Thirty two (18.9%) patients underwent PCR testing for SARS-CoV-2. Of these 32 patients, 28.1% were positive for IgG. During the pandemic period, 19 (11.2%) had a new symptom/sign of their disease. The rate of patients with a new symptom/sign was higher in the seropositive group than in the seronegative group (20.0% vs. 8.5%, p= 0.046). Conclusion: We found that SARS-CoV-2 seroprevalence was 23.5% in children with a diagnosis of rheumatic disease. The distribution of the primary disease and medical therapies used were similar between seropositive and seronegative patients. We found that patients with a new symptom/sign of their disease was higher in the seropositive group than in the seronegative group.
Objective: To investigate the presence of cCMV infection and the CMV-DNA virus in the newborns who applied for newborn hearing screening test (NHST) and CMV-DNA viruria with physical, mental-motor development and hearing status of cCMV cases in the second year of age. Patients and Methods: CMV-DNA was investigated in 1150 newborns’ oral swabs (0-21 days) by polymerase chain reaction kit and urine of patients with positive CMV-DNA in saliva. Transient Evoked Otoacoustic Emission test was performed for NHST. Results: CMV-DNA was posititve in saliva of 38 (3.3%) newborns and urine of 10 out of 37 newborns. The prevalence of cCMV was 0.87% (95% CI=0.697-1.042). All newborns passed the NHST. In newborns with cCMV:jaundice in 60% (6/10), low birthweight in 40% (4/10), small for gestational age in 50% (5/10) of them. Jaundice was the most significant variable (P
Objectives: This study aimed to determine the predictive factors of BK virus viremia/nephropathy in kidney transplant recipients and to evaluate the effects of low-dose tacrolimus plus everolimus.Materials and Methods: This study included 3654 kidney transplant recipients. The patients were divided into 2 groups: group 1 were BK virus negative (n = 3525, 96.5%) and group 2 were BK virus positive (n = 129, viremia 3.5%, nephropathy 1%). Predictive factors were determined by receiver operating characteristic curve analysis and logistic regression models. We also divided and analyzed patients with BK virus viremia/nephropathy into 2 groups according to immunosuppressive changes. Group 2a had been switched to low-dose tacrolimus plus everolimus (n = 54, 41.9%), and group 2b had been switched to other immunosuppressive protocols (n = 75, 58.1%).Results: We found that use of anti-T-cell lymphocyte globulin and tacrolimus, deceased donor transplant, and rejection were predictive factors for BK virus viremia/nephropathy. In addition, patients who had low-dose calcineurin inhibitor plus mammalian target of rapamycin inhibitor regimens showed a low rate of BK virus development (only 6.2% of all cases). In Group 2a, both the BK polyomavirus-associated nephropathy rate (n = 23 [42.6%] vs n = 12 [16%] in group 2b; P = .001) and viral load (DNA > 10(4) copies/mL) (n = 49 [90.7%] vs n = 27 [36%] in group 2b; P = .001) were increased versus group 2b. Graft function, graft survival, viral clearance, and rejection rate were similar between the groups after protocol change.Conclusions: BK virus viremia/nephropathy rate was lower in patients who received low-dose calcineurin inhibitor plus mammalian target of rapamycin inhibitor protocols; the low-dose tacrolimus plus everolimus switch protocol after BK virus was more effective and safe than other protocols.
Ganciclovir-resistant cytomegalovirus (CMV) strains are reported following long-term antiviral agent use, especially for immune-suppressive patients. In this study, it was aimed to investigate the mutations in the UL97 gene of CMV, which causes ganciclovir (GCV) resistance by genotypic and phenotypic methods in patients who developed CMV infection following hematopoietic cell (HCT) or solid organ transplantation (SOT). Thirty patients who had HCT or SOT in Mediterranean University Hospital and developed CMV infection during routine follow-up with a viral load of CMV over 1000 copies/mL were included in the study. CMV DNA was analyzed by an automated system (Cobas Ampliprep/COBAS TaqMan CMV Test, Roche Diagnostics, Germany) quantitatively. DNA sequence analysis of the regions including codons 420-664 in the UL97 gene region was done by the Sanger sequencing method to detect mutations causing antiviral resistance and compared with defined mutations. In order to investigate antiviral resistance by phenotypic methods, heparinized blood samples of the patients were collected, 'buffy coat (leukocyte layer)' was inoculated into MRC-5 cells by centrifugation method and CMV growth in these cells was controlled with monoclonal antibodies when growth was detected, virus titer was determined and plaque reduction test was applied as recommended. It was determined that 22 of the 30 patients were HCT recipients and eight were SOT (five kidney, three liver) recipients. When the CMV serology pattern of the patients was evaluated before transplantation, 29 (96.7%) patients were found to be seropositive and one (3.3%) patient was found to be seronegative. Totally, nine CMV UL97 mutations were detected in seven (23.3%) pediatric patients who had HCT, including six seropositive and one seronegative case. In addition, one mutation (D605E) not known to cause GCV resistance was detected in a seronegative recipient and three previously unidentified mutations were detected (1474T, F499S, V559A) in a seronegative recipient. Five of the mutations defined were UL97 mutations with a defined clinical resistance against GCV in each of the five recipients (C603W, C592G, H520Q, M460V, A594T). In the plaque reduction test using 3 µM, 12 µM, 48 µM and 96 µM concentrations of GCV in CMV strains, the IC50 value was determined to be ≥ 8 µM for the five CMV strains, and the phenotypic presence of GCV resistance was shown. Clinical resistance associated with CMV UL97 mutation was detected in five (22.7%) of 22 patients who had HCT. GCV resistance was also demonstrated in these patients by phenotypic methods. No UL97 mutation was detected in the patients who had SOT.
OBJECTIVES:BK polyomavirus-associated nephropathy is a clinicopathological entity that negatively affects graft function in kidney transplant recipients. We compared the efficacy of leflunomide and cidofovir to treat BK polyomavirus-associated nephropathy in pediatric kidney transplant recipients. MATERIALS AND METHODS:Medical records of pediatric recipients with BK viremia for the period 2004 through 2019 were reviewed retrospectively, and patients diagnosed with BK polyomavirusassociated nephro-pathy were included in the study. A serum BK virus level above 104 copies/mL was accepted as BK viremia. We defined BK polyomavirusassociated nephropathy as detection of BK virus SV40 antigen on immunochemistry staining of renal graft tissue accompanied by signs of tubulointerstitial nephritis or elevated serum creatinine in addition to BK viremia. RESULTS:Of 304 kidney transplant recipients, 53 had persistent BK viremia; 36 of these patients (61.1% male) were included in the study with the diagnosis of BK polyomavirus-associated nephropathy. Twelve patients (33.3%) received cidofovir, and 14 (38.8%) received leflunomide. Results were similar between the cidofovir and leflunomide groups for serum creatinine level at last follow-up (0.91 ± 0.29 vs 0.94 ± 0.37 mg/dL, respectively; P = .843) and graft failure rate (8.3% vs 14.2%, respectively; P = .632). Graft failure was observed in 8.3% of patients with BK polyomavirus-associated nephropathy. CONCLUSIONS:Leflunomide and cidofovir showed similar efficacy for treatment of BK polyomavirus-associated nephropathy.
Background Pediatric patients with a diagnosis of rheumatic disease are at increased risk for infectious diseases due to immune dysregulation arising fromthe disease itself, as well as immunoregulatory or immunosuppressive drugs they use. However, there are studies reporting that COVID-19 disease has a moderate course in children with rheumatic disease. Objectives This study aims to determine the seroprevalence of SARS-CoV-2 in children with rheumatic disease during the COVID-19 pandemic, to evaluate the effects of immunosuppressive drugs and biological agents on seroprevalence of COVID. Methods Between September 2020 and September 2021, patients aged 2-18 years with a diagnosis of and with a follow-up period of more than 6 months were included in the study. Patients were selected by “simple random sampling” method. Anti-SARS-CoV-2 antibodies (IgG and IgA) against the S1 domain of the SARS-CoV-2 spike protein were investigated with a micro ELISA kit. Results 170 patients, 92 (54.1%) girls, with a mean age of 12.16±4.18 years, were included. The median age at diagnosis was 7.59 (IQR 4.33-11.30) years, and the median follow-up time after diagnosis was 3.24 (IQR 1.87-5.99) years. Primary disease distribution was presented on Figure 1. The co-morbid diseases as obesity, hypertension and chronic kidney disease was present in 4.7%, 9.4% and 5.3% of patients, respectively. The distribution of medications was as follows; colchicine 101 patients (59.4%), Disease Modifying Anti-Rheumatism Drugs 49 (28.8%), steroid 25 (14.7%), and biological agents 28 (16.5%). Figure 1. Distribution of patients according to primary rheumatologic diagnosis Anti-SARS-CoV-2 Ig G antibody was positive in 40 (23.5%) of the patients. Demographic characteristics and treatment-related variables were similar between SARS-CoV-2 IgG seropositive and seronegative patients (Table 1). Table 1. Characteristics of patients who are seropositive and seronegative for anti-SARS-CoV-2 Ig G Variable Anti-SARS-CoV-2 IgG negative patients (n=130) Anti-SARS-CoV-2 IgG positive patients (n=40) p Age (years) 11.96±4.19 12.80±4.14 0.528 Sex (%)Female 67 (%72.8) 25 (%27.2) 0.150 Median age at diagnosis (years) 7.56±4.03 8.69±4.75 0.195 Median follow-up time after diagnosis (years) 4.39±3.27 4.11±3.19 0.891 Diagnosis (%) FMF and other autoinflammatory disease 62 (%78.5) 17 (%21.5) 0.166 Juvenile idiopathic arthritis 39 (%78.0) 11 (%22.0) SLE ve other autoantibody related diseases 16 (%80.0) 4 (%20.0) Behçet’s disease 8 (%66.7) 4 (%33.3) Vasculitis 5 (%55.6) 4 (%44.4) MEFV mutation Homozygous 30 (%75.0) 10 (%25.0) 0.991 Heterozygous 33 (%76.7) 10 (%23.3) No mutation 36 (%75.0) 12 (%25.0) Presence of colchicine usage Yes 76 (%75.2) 25 (%24.8) 0.396 No 54 (%78.2) 15 (%21.7) Median colchicine dose (mg/day) 1.09±0.44 1.13±0.42 0.842 Presence of DMARD usage Yes 37 (%75.5) 12 (%24.5) 0.499 No 93 (%76.9) 28 (%23.1) Presence of steroid usage Yes 17 (%68.0) 8 (%32.0) 0.202 No 113 (%77.9) 32 (%22.1) Median steroid dose (mg/day) 10.50±8.91 14.71±11.95 0.333 Presence of biological agent usage Yes 21 (%75.0) 7(%25.0) 0.505 No 109 (%76.8) 33(%23.2) Thirty-eight (22.4%) of the patients had close contact with an individual diagnosed with COVID-19. Thirty two (18.9%) patients underwent PCR testing for SARS-CoV-2; only 4 (2.4%) had positive. Of these 32 patients, 28.1% were positive for IgG. IgG seropositivity was observed in 3 (75.0%) of 4 patients with PCR positivity. Conclusion We found the SARS-CoV-2 seroprevalence of 23.5% in children with a diagnosis of rheumatic disease. It seems that primary rheumatological diagnosis does not affect COVID seropositivity in children. Disclosure of Interests None declared
Diagnosis of COVID19 is based on reverse transcription-polymerase chain reaction (RT-PCR) testing of nasopharyngeal swab (NPS) samples. As NPS sampling is a discomforting invasive procedure, studies were conducted to investigate the performance of saliva and mouthwash (MW) samples in RT-PCR. There is limited data about MW samples. We have developed a new method for concentrating gargle and mouthwash (GMW) samples to be used in RT-PCR. In our study, we aimed to investigate the performance of concentration of GMW samples in detection of SARS-CoV-2. A paired sample of NPS and GMW samples were collected from patients in 11 centers in Turkey. MW samples were concentrated using MyMagiCon-RW100® (Bio-T, Istanbul, Turkey). NPS, GMW and concentrated GMW samples were tested by RT-PCR for the presence of SARS-CoV2 and the results were compared. The viral RNA was detected in 47.5% of NPS samples, in 28.8% of GMW before concentration and in 37.5% GMW samples after concentration. Concentration of samples increased the number of samples in which SARS-CoV2 RNA was detected by 16.6%. The RT-PCR of concentrated GMW samples yielded better results than the RT-PCR of NPS samples in two centers. Concentrated GMW sampling can be an alternative method to NPS sampling in rapid and accurate diagnosis of COVID-19.
Abstract Background BK virus viremia or nephropathy is very important for graft survival and functions in renal transplant recipients. We aimed to determine the predictive factors of BK virus viremia or nephropathy, to discuss the effect of swiching to low dose tacrolimus plus everolimus and the viral load in kidney transplant patients. Methods 3654 kidney transplant recipients were included in the study. Firstly, the patients were divided into two groups (Group 1: BKV (-) (n = 3525, 96.5%), Group 2: BKV viremia (+) (n = 129, viremia 3.5%, nephropathy 1%) were evaluated. Secondly, patients with BKV viremia / BKPyVAN were divided into two groups according to immunosuppressive changes (Group 2a: swiching to low dose tacrolimus plus everolimus (n = 54, 41.9%), Group 2b: swiching to other immunosuppressive protocols (n = 75, 58.1%) were evaluated. Thirdly, the cut-off value of the viral load amount (≥ 104 and < 104) was discussed. Results History of rejection, elderly recipient, cadaveric transplantation, use of anti-thymocyte globulin, tacrolimus and CMV viremia are predictive factors for BKV development. It was shown that the rate of viremia/nephropathy was highest in tacrolimus plus mycophenolic acid protocols, The use of low dose Tacrolimus plus Everolimus as an exchange protocol after BKV viremia or BKPyVAN had a positive effect on the outcomes, a viral load ≥ 104 was shown to be a significant cut-off value in terms of nephropathy development and graft survival. Conclusion BK virus development in kidney transplant recipients is multifactorial and it was thought that preventive measures may be more important than treatment.
Aim: To investigate the prevalence of congenital cytomegalovirus(c CMV ) infection in newborns applied for newborn hearing screening test(NHST) and to examine the physical, mental-motor development and hearing status of children with cCMV in the second year of life. Study desing: Prospective cohort study. CMV-DNA was investigated in oral swabs by LightMix Human Cytomegalovirus V17.0(TIB MOLBIOL, Germany) polymerase chain reaction kit. The same method was used to examine CMV in the urine of patients who were positive for CMV-DNA in their saliva. Transient Evoked Otoacoustic Emission and Auditory Brainstem Response (TEOEA)(Acuscreen, Madsen, Denmark) tests were performed stepwise for NHST.Subjects: 1150 newborns’ (0-21 days) oral swabs were taken during NHST screening from newborns. Congenital CMV was diagnosed in 10 newborns. In the second year of follow-up, 8 of 10 cases with cCMV were checked for the sequelaes.Results: In 38(3.3%) of newborns in saliva and 10 of 37 newborns’ in urine were found CMV -DNA positive. The prevalence of cCMV was 0.87%(10/1150). All newborns passed the NHST. In newborns with c CMV infection: jaundice in 60%(6/10), low birthweight in 40%(4/10), small for gestational age in 50% (5/10) of them. In multivariate analysis, presence of jaundice was the most significant variable ( p <0.001, OR:23,411, 95%CI=5,772-94,960). In the second year of follow-up, 8 cases had CMV-DNA in their urine and a sensorineural hearing loss was detected in an infant. Conclusion: The cCMV infection rate is 0.87% in a population with high maternal seropositivity. When diagnosing cCMV, saliva samples may give false-positive results and urine should be tested. CMV-DNA could still be detected in urine samples for up to two years after birth. In highly seroimmune populations sequelaes may occur during follow-up, comprehensive studies are needed on this subject.
Molecular diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by real-time reverse transcription polymerase chain reaction (RT-PCR) in respiratory specimens is considered the gold standard method. This method is highly sensitive and specific but it has some limitations such as being expensive and requiring special laboratory equipment and skilled personnel. RapidFor™ Antigen Rapid Test Kit is a commercially available Ag-RDT which is produced in Turkey and designed to detect the nucleocapsid antigen of SARS-CoV-2 in nasopharyngeal swab samples. The aim of this study was to evaluate the performance of this novel SARS-CoV-2 antigen detection considering the RT-PCR method as the gold standard. Four hundred forty-four nasopharyngeal swab samples which were collected from the patients who met clinical criteria of COVID-19 from ten centers in Turkey between September 2020 and February 2021 were included in the study. All the nasopharyngeal swab samples were tested for SARS-CoV-2 RNA using commercial RT-PCR kits (Bioeksen and A1 Lifesciences, İstanbul, Turkey) according to the manufacturer’s instructions. Viral loads were assessed according to the cycle threshold (Ct) values. RapidFor™ SARS-CoV-2 antigen test (Vitrosens Biotechnology, Istanbul, Turkey) was used to investigate the presence of SARS-CoV-2 antigen in all samples following the manufacturer’s instructions. Out of 444 nasopharyngeal swab samples tested, 346 (77.9%) were positive and 98 (22.1%) were negative for SARS-CoV-2 RNA by RTPCR. Overall sensitivity of the RapidFor™. Antigen Rapid Test Kit was 80.3% whereas specificity was found to be 87.8%. Positivity rate of rapid antigen test in samples with Ct values over 25 and below 30 was 82.7%, while it increased to 95.7% in samples 20 ≤ Ct < 25 and reached 100% in samples with Ct values below 20. RapidFor™ SARS-CoV-2 Ag test might be a good choice in the screening of symptomatic and asymptomatic patients and their contacts for taking isolation measures early, with advantages over RT-PCR as being rapid, easy and being applicable in every laboratory and even at point of care.
Background: The BIOCHIP mosaic-based indirect immunofluorescence technique is a practical, standardized test, and it has been used successfully in the diagnosis of autoimmune bullous dermatosis in recent years. Objectives: The study aimed to examine the diagnostic value of the BIOCHIP to identify dermatitis herpetiformis (DH) in patients with chronic pruritus (CP). Materials and Methods: This single-center case–control study included patients who applied to a dermatology clinic between July 2020 and December 2020. The diagnosis of DH was confirmed by direct immunofluorescence (DIF) test. In cases without DIF positivity, the diagnosis was established with a complete response to a long-term gluten-free diet and/or a swift response to dapsone treatment. All analyses were performed using SPSS version 21 (SPSS Inc., Chicago, IL, USA). The diagnostic performance of the variables was evaluated using receiver operating characteristic (ROC) curve analysis. P values < 0.05 were considered statistically significant. Results: GAF 3X (gliadin analog fusion peptide), as measured by the BIOCHIP method, had an area under the ROC curve of 0.854 (95% confidence interval: 0.688–1.000) for DH diagnosis with sensitivity, specificity, positive predictive, and negative predictive values of 72.73%, 100%, 100%, and 93.62%, respectively, demonstrating an overall accuracy of 94.55%. Conclusion: DH could be determined with nearly excellent accuracy by BIOCHIP GAF 3X analysis among patients with CP. BIOCHIP-based determination of GAF 3X was found to be superior to Enzyme-Linked ImmunoSorbent Assay (ELISA)-based determination of GAF 3X.
Objective: Detection of the etiological agents in patients with acute diarrhea is challenging due to a wide variety of pathogens. The aim of this study is to evaluate the diagnostic performance of BD Max Enteric Bacterial Pathogens (EBP) PCR assay in patients with diarrheal illness. Methods: Between 1 January 2014 and 31 May 2015, stool samples from pediatric or adult patients with diarrhea submitted for routine analysis of bacterial stool pathogens were included in the study. We compared the BD Max EBP PCR assay to culture for the detection of Salmonella spp., Shigella spp., Campylobacter jejuni, and Campylobacter coli and an EIA for Shiga toxins 1 and 2. Discordant results were adjudicated by either antigen detection methods or Film array GI Panel. Results: When coinfections were excluded, the positive percent agreement values for the BD Max EBP assay (PPA) was 100% and negative percent agreement (NPA) was between 98.0%-99.7%, when compared with culture and EIA. After discrepant analysis, the PPA values for the BD Max EBP assay was 100% and NPA was between 99.5%-100%. Conclusion: The BD Max EBP assay showed a high correlation rate with conventional and molecular methods for the detection of stool pathogens.